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EC number: 232-087-8
CAS number: 7785-70-8
Examination of the influence on the pregnant rat and the fetus by oral
administration summary of maternal clinical symptoms
Test Group 1: Control
Test Group 2: 250 mg/kg bw/day
Test Group 3: 1000 mg/kg bw/day
No remarkable observations
deceased dam no. 53; ** * deceased dam no. 56; # dams no. 53, 56 died
prematurely due to regurgitation and aspiration of the test substance
In a prenatal developmental toxicity
study performed in accordance with OECD guideline 414 and in compliance
with GLP, camphene in sesame oil was administered through gavage to
groups of Sprague-Dawley pregnant rats (20/dose) at dose levels of 0
(vehicle control), 250 and 1000 mg/kg bw/day from Day 6 to 15 of
pregnancy. Dams were observed twice daily for behaviour, external
appearance, mortality and faeces. Body weights, food and water
consumption were noted daily. Caesarean sections were performed on Day
20 of pregnancy and the ovaries and uterine contents were recorded.
Fetuses were weighed and examined for external, visceral and skeletal
No treatment-related mortality was
observed at any dose level. At 1000 mg/kg bw/day, 6/20 dams showed
reduced motor activity and salivation after first dosing, two of them
salivation after second dosing. The reactions occurred within 5-20
minutes after administration and lasted for 20-60 minutes, 1-2 hours or
2-6 hours. Body weights remained within the normal range and body weight
gain showed no influence of the test material. Transient impairment of
the food consumption by the highest tested dose (1000 mg/kg bw/day) was
observed on the 7th, 8th and 9th gestation day by 6%, 22% and 10%,
respectively. Treatment did not influence drinking-water consumption. No
treatment-related pathological changes were detected at autopsy. No dead
fetuses observed in control or treatment groups. No treatment-related
effects were observed on uterus and placentae weights, conception rate,
mean number of corpora lutea and implantation sites, pre-implantation
loss and number of viable fetuses, sex distribution of fetuses and
weight of fetuses. External macroscopic examination, examination of soft
tissue and skeletal examination revealed no treatment-related
biologically and/or statistically significant variations/retardations.
Number of resorptions and consequently the post-implantation loss were
increased slightly (statistically non- significant) at 1000 mg/kg bw/day.
conclusion, the no-observed-effect level (NOEL) for maternal and fetotoxicity
of camphene administered orally (gavage) was considered to be 250 mg/kg
bw/day in Sprague-Dawley rats. Therefore, camphene is not considered to
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